Clinicians who manage glaucoma know that one medication alone isn’t always enough. Some patients need two or three eye drops to reach their target IOP. Most ophthalmologists feel optimistic that, in the future, they will see new medications capable of lowering IOP with a single drop. But the same doctors have been confounded at the absence of the most simple, logical next step for their patients — a single combination drop containing medications that have been available for years.

After discussing this gap with glaucoma specialists and better understanding the implications of poor patient compliance, we worked with glaucoma specialists to develop a line of products called Simple Drops. Our goal was to create preservative-free combination drops that address what ophthalmologists see as the greatest concerns for their glaucoma patients who use eye drops: compliance, cost, and, ocular surface disease (OSD).

Compliance, Cost, and OSD

Physicians tell us over and over, “If patients can get glaucoma medications on the eye, most of them will reduce their pressures and prevent progression.”

Compliance means success, and the barriers preventing predictable compliance are the primary concern of most physicians. The literature clearly shows that compliance to drop therapy declines dramatically as the number of different medications increases.^1,2 With more bottles, it can become challenging to remember what medications to take and when to take them. Medications also can be inconvenient when they interrupt work and other activities several times per day.

In addition, the more eye drops patients use, the more likely they will experience unwanted side effects to the ocular surface that are often caused by preservatives, such as BAK, contained within the drops. Redness, dryness, and overall ocular discomfort negatively affect quality of life and, thus, can also affect compliance.

Finally, many patients have trouble affording the two, three, or four prescription medications per month. Affordability is particularly important for patients who have glaucoma, because they are usually older and may need to purchase prescriptions for other health problems. If patients must choose between getting their car repaired and buying their glaucoma medications, they might skip a month of medication.

When we began working with glaucoma specialists 2 years ago, they helped us understand the frustration they and their patients feel every day about these unmet needs. Working with a team of key opinion leaders and actual patients, we have been able to meet these needs with an affordable, preservative-free, single-bottle premium product.

Physician-Designed Therapies

The glaucoma community told us that compliance is difficult, affordability is important, and they would love to have a product that did not inflame the ocular surface. For us, the project was a perfect fit because our company’s vision is to deliver high-quality, innovative medications priced affordably for broad accessibility.

Physicians worked shoulder to shoulder with our company through 2 years of development to perfect formulations that meet their goals through the combination of commonly used, FDA-approved glaucoma medications.

The resulting Simple Drops products may be customized, but the common formulas include:

• TIM-LAT (timolol 0.5%/latanoprost 0.005%)
• BRIM-DOR (brimonidine 0.15%/dorzolamide 2.0%)
• TIM-BRIM-DOR (timolol 0.5%/brimonidine 0.15%/dorzolamide 2.0%)
• TIM-DOR-LAT (timolol 0.5%/dorzolamide 2.0%/latanoprost 0.005%)
• TIM-BRIM-DOR-LAT (timolol 0.5%/brimonidine 0.15%/dorzolamide 2.0%/latanoprost 0.005%).

Physicians order Simple Drops online or by fax, and a 60-day supply is sent to the patients’ homes on a recurring basis, so they never run out of medication. The 2-month supply of Simple Drops costs the same as — or, in many cases, less than — a 2-month supply of the generic drugs it contains. And because the drops are preservative-free, ocular surface toxicity is much improved from the multi-drug regimen.

The underlying goals for these glaucoma medications, and all of our products, are quality and patient safety. Physicians and patients can feel assured that we are thorough and transparent about all safety measures. We use high-quality, sterile, FDA-approved ingredients, and the drops are manufactured at our PCAB-accredited, FDA-inspected facilities. When we ship medication to patients, we include our SteriCheck certification, which shows the sterility results of their purchase. All formulations come in a bottle design that has a patented and FDA-approved one-way valve to prevent the risk of contamination.

Positive Results

Imprimis has a history of delivering a variety of innovative combination formulations for sedation, dilation, inflammation, and infection to our more than 1,700 customers. Our LessDrops formulations are typically prescribed by ophthalmologists for disease treatment or postoperative care following LASIK, PRK, cataract, and other ocular surgeries.

Other ophthalmology offerings include Dropless Cataract Surgery sterile injectable compounded formulations and the MKO Melt, which is used for sublingual conscious sedation to reduce or eliminate the need for an IV during surgery.

Development of Simple Drops has been uniquely rewarding. Our customers are excited about the results. We love to hear that a patient has avoided surgery because compliance with one-drop therapy has reduced his IOP. By simplifying regimens and costs while lowering toxicity, we transform effective, FDA-approved medications into a more effective therapy that really performs. We think Simple Drops represent a significant advancement in the field of ophthalmology and an important new tool for physicians managing glaucoma. GP

References

1. Robin AL, Covert D. Does adjunctive glaucoma therapy affect adherence to the initial primary therapy? Ophthalmology. 2005; 112(5):863-868.
2. Olthoff CM, Schouten JS, van de Borne BW, Webers CA. Noncompliance with ocular hypotensive treatment in patients with glaucoma or ocular hypertension: an evidence-based review. Ophthalmology. 2005;112:953-961.